Clinical Trials /

NCT01230866

Description:

The purpose of this study is to compare the effects (good and bad) on patients with prostate
cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks)
with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of
the treatments are similar or better.

Recruiting Status:

Phase:

URL:

Trial Eligibility

Document

Title

Official Title: A Phase III Prospective Randomized Trial of Standard-fractionation vs. Hypo-fractionation With Proton Radiation Therapy for Low Risk Adenocarcinoma of the Prostate

Clinical Trial IDs

ORG STUDY ID:
GU002-10

NCT ID:
NCT01230866

Conditions

Prostate Cancer

Purpose

The purpose of this study is to compare the effects (good and bad) on patients with prostate
cancer by comparing the standard dose of radiation therapy (44 treatments over 8½-9 weeks)
with a higher daily dose of radiation (5 treatments over 1-2 weeks) to see if the effects of
the treatments are similar or better.

Trial Arms

Name

Type

Description

Interventions

Proton Radiation Hypofractionation

Other

5 fractions (7.6 Gy(RBE) x 5)

Proton Radiation Standard Fractionation

Active Comparator

44 fractions (1.8 Gy(RBE) x 44)

Eligibility Criteria

Inclusion Criteria:
- Histologically confirmed prostate adenocarcinoma within 365 days prior to
randomization.
- History/physical examination with digital rectal examination of the prostate and
baseline toxicity assessment within 90 days prior to randomization.
- Histological evaluation of prostate biopsy with assignment of a Gleason score to the
biopsy material;Gleason score must be in the range of 2-6. > 6 cores are strongly
recommended.
- PSA values < 10 ng/ml within 90 days prior to randomization. Either done prior to
biopsy or at least 21 days after prostate biopsy.
- Clinical stages T1a-T2a N0 M0 (AJCC Criteria 7th Ed.). Staging must be done by
treating investigator.
- No pelvic lymph nodes > 1.5 cm in greatest dimension unless the enlarged lymph node
is biopsied and negative.
- Patients must be at least 18 years old.
- ECOG performance status 0-1 (appendix I) documented within 90 days prior to
randomization.
- IPSS score < 16.
- Patients must give IRB approved, study specific, informed consent.
- Patients must complete all mandatory tests listed in section 4.0 within the specified
time frames.
- Patients must be able to start treatment within 56 days of randomization.
Exclusion Criteria:
- Previous prostate cancer surgery to include: prostatectomy, hyperthermia and
cryosurgery.
- Previous pelvic radiation for prostate cancer.
- Androgen deprivation therapy prior to radiation is allowed. However, it is not
acceptable if continued during radiation or as adjuvant therapy.
- Active rectal diverticulitis, Crohn's disease affecting the rectum, or ulcerative
colitis.
- Prior systemic chemotherapy for prostate cancer.
- History of proximal urethral stricture requiring dilatation.
- Current and continuing anticoagulation with warfarin sodium (Coumadin, heparin,
low-molecular weight heparin, Clopidogrel bisulfate (Plavix),or equivalent. (Unless
it can be stopped to manage treatment related toxicity, to have a biopsy if needed,
or for marker placement).
- Any major medical, addictive or psychiatric illnesses which would affect the consent
process, completion of treatment and/or interfere with follow-up. Consent by legal
authorized representative is not permitted in this study.
- Evidence of any other cancer within the past 5 years and < 50% probability of a 5
year survival. (Prior or concurrent diagnosis of basal cell or non-invasive squamous
cell cancer of the skin is allowed).

Maximum Eligible Age:

N/A

Minimum Eligible Age:

18 Years

Eligible Gender:

Male

Healthy Volunteers:

No

Primary Outcome Measures

Measure:

To assess if hypo-fractionation will result in 2-year freedom from failure (FFF) that is non-inferior to 2-year FFF following standard fractionation. FFF will be measured by recurrence, metastasis, PSA or start of salvage therapy.

Time Frame:

At 5 years post treatment completion +/- 90 days

Safety Issue:

Description:

The events for FFF will be the first occurrence of clinical failure (local recurrence, regional recurrence, or distant metastasis), biochemical failure by the Phoenix definition (PSA ≥ 2 ng/ml over the current nadir PSA),or the start of salvage therapy including androgen deprivation.

Secondary Outcome Measures

Measure:

To determine the incidence of grade 2 or greater GU and GI toxicity in each of the regimens